(209 days)
The NeuroPort™ Array System (Neuroport Electrode) is intended for temporary (<30 days) recording and monitoring of brain electrical activity.
The NeuroPort™ Array System (Neuroport Electrode) is comprised of a base approximately 4 mm x 4 mm dimensionally with 100 microelectrodes. Each microelectrode is approximately 1 mm long. The lead connects the microelectrode array to the percutaneous pedestal connector.
The request asks for a description of acceptance criteria and the study proving the device meets those criteria, based on the provided text. However, the provided text is a 510(k) summary and FDA clearance letter for the NeuroPort™ Cortical Microelectrode Array System, largely relying on substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, specific performance metrics beyond biocompatibility and recording electrical activity) are not explicitly available in the provided document.
Here's the information that can be extracted or reasonably inferred from the text:
1. A table of acceptance criteria and the reported device performance
Based on the 510(k) summary, the core "acceptance criteria" are implied by the performance data, which aims to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility for intended use (temporary, <30 days) | "NeuroPort™ Array System is deemed biocompatible for its proposed intended use" |
| Ability to record brain electrical activity | "NeuroPort™ Array System records brain electrical activity" |
| Same intended use as the predicate device (Ad-Tech Spencer® Depth Electrode) | "The NeuroPort™ Array System has the same intended use as compared to the predicate device." |
| Technological substantial equivalence to predicate device | "Based on the supporting performance data, the NeuroPort™ Array System is capable of recording brain electrical activity and is therefore substantially equivalent to the predicate device technologically." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "non-clinical testing" as the basis for performance. It does not specify a "test set" in the context of human subjects or a clinical study for performance metrics.
- No sample size for a test set is provided.
- Data provenance (country of origin, retrospective/prospective) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. The "performance data" refers to non-clinical testing rather than expert-adjudicated clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided, as there is no described clinical test set with human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study is not mentioned. This device is a microelectrode array for recording, not an AI-based diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI algorithm. The device itself is a standalone hardware product for recording brain electrical activity. The performance described relates to the device's physical and functional capabilities (biocompatibility, electrical recording), not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility, the ground truth would be established through biocompatibility testing standards (e.g., ISO 10993 series) which involve in-vitro and/or in-vivo animal tests to assess cytotoxicity, irritation, sensitization, etc.
- For the ability to record brain electrical activity, the ground truth would be established through bench testing and possibly animal or cadaveric studies to demonstrate stable and accurate signal acquisition, likely against known electrical signals or established physiological measurements.
- The document implies that these were evaluated against established scientific and engineering principles and recognized standards for medical device safety and performance, rather than clinical "ground truth" like pathology or expert consensus in a diagnostic context.
8. The sample size for the training set
- Not applicable/not provided. This is a hardware device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/not provided.
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MAR 2 9 2005
510(K) SUMMARY NeuroPort™ Cortical Microelectrode Array System (Neuroport Electrode)
| Submitter Name: | Cyberkinetics, Inc. |
|---|---|
| Submitter Address: | 100 Foxborough Boulevard, Suite 240Foxboro, MA 02035 |
| Contact Person: | Nandini Murthy, V.P. Regulatory Affairs and Quality Systems |
| Phone Number: | (508) 549-9981, Extn 103 |
| Fax Number: | (508) 549-9985 |
| Date Prepared: | Aug 30, 2004 |
| Device Trade Name: | NeuroPort™ Cortical Microelectrode Array System (NeuroportElectrode) |
| Device Common Name: | Depth electrode |
| Predicate Devices: | Ad-Tech Spencer® Depth Electrode |
| Device Description: | The NeuroPort™ Array System (Neuroport Electrode) iscomprised of a base approximately 4 mm x 4 mm dimensionallywith 100 microelectrodes. Each microelectrode is approximately1 mm long. The lead connects the microelectrode array to thepercutaneous pedestal connector. |
| Intended Use: | The NeuroPort™ Array System (Neuroport Electrode) isintended for temporary (<30 days) recording and monitoring ofbrain electrical activity. |
| Performance Data: | Results of non-clinical testing indicate that the NeuroPort™Array System is deemed biocompatible for its proposed intendeduse and that the NeuroPort™ Array System records brainelectrical activity. |
| Conclusion: | The NeuroPort™ Array System has the same intended use ascompared to the predicate device. Based on the supportingperformance data, the NeuroPort™ Array System is capable ofrecording brain electrical activity and is therefore substantiallyequivalent to the predicate device technologically. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three horizontal bars above a wavy line.
MAR 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nandini Murthy Mis. Nancident, Vice President Regulatory Affairs and Quality Systems Cyberkinetics, Inc. 100 Foxborough Boulevard, Suite 240 Foxborough, Massachusetts 02035
Re: K042384
K042364
Trade/Device Name: Neuroport™ Cortical Microelectrode Array System (Neuroport™ Electrode) Regulation Number: 21 CFR 882.1330, 21 CFR 882.1835 Regulation Name: Depth electrode; Physiological signal amplifier Regulatory Class: II Product Code: GZL and GWL Dated: February 8, 2005 Received: February 9, 2005
Dear Ms. Murthy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. D're() personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to conninered processified in accordance with the provisions of the Federal Food. Drug. de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r our may, diererere, mains of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (600 a0070) vols. Existing major regulations affecting your device can thay be subject to back as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must of any i ederal statutes and regisements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY an the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and n your a FDA finding of substantial equivalence of your device to a legally prematicated predicated. The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please n you desire of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miletimational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stpt. Rlurdu
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042384
Neuroport™ Microelectrode Array System (Neuroport Device Name: Electrode)
Indications For Use:
The intended use of the Cyberkinetics, Inc. Neuroport Microelectrode Array System is The monded ase of the Oyour-ling and monitoring of brain electrical activity
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hust Rhodes
(Divisi Division of General, Restorative. and Neurological Devices
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510(k) Number___ ko42384
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).